Aerosol delivery device

ABSTRACT

An aerosol delivery system is disclosed that is a single-use (disposable) continuous nebulizer system designed for use with mechanically ventilated patients to aerosolize medications for inhalation with a general purpose nebulizer, or for connection with devices usable in endoscopic procedures. The system separates the liquid reservoir from the nebulization process taking place either at the adapter hub, where it fits into an endotracheal tube (ETT), or a gas humidifier, where the aerosol may treat a gas used in an endoscopic procedure, with a multi-lumen tube configured to nebulize liquid and air at its distal end. The refillable liquid reservoir is mounted away from the immediate treatment zone, avoiding orientation issues associated with other types of nebulizers having a self-contained reservoir. The system can produce aerosols having a wide range of droplet sizes, depending upon central lumen diameter, with values of MMAD that range from 4 to 30 μm.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/376,644, filed Aug. 24, 2010, the entirety of which is herebyincorporated herein by reference.

TECHNICAL FIELD

This disclosure relates to an aerosol delivery device for nebulizing aliquid for administration or delivery to a predetermined location in theinterior or exterior of a human or animal. More particularly, thisdisclosure relates to an aerosol delivery device for use in ventilatorapplications to administer or deliver a liquid medicament or otherliquid substance in aerosol form to a human's or animal's respiratorysystem, or for use in endoscopic applications to administer or deliver aliquid medicament or other liquid or substance in aerosol form.

BACKGROUND

Conventional jet nebulizers require a significant amount of air fortheir operation, typically 15 liters per minute (L/min). With a typicalI:E ratio of 1:3 and 15 breaths per minute (BPM), such a nebulizer wouldgenerate 1,000 milliliters (mL) of aerosol during a typical 4-secondperiod of inspiration expiration. The tidal volume of a healthy adultmay be on the order of 700 mL and that of a pediatric patient willgenerally be far less. Consequently, the large air flows provided byconventional jet nebulizers, when introduced into a ventilator circuit,may cause the sensing mechanisms of the ventilator circuit to producealarms and potentially shut down its operation.

Nebulizer systems, such as micro pump systems, do not require a supplyof air flow for their operation. Thus, they may be used in neonatal andadult ventilator circuits without fear of conflicting with theventilator circuit sensors. Although micro pump nebulizer systemsaddress the potential air flow problems that may occur when used withventilator circuits, the attachments for a micro pump nebulizer systemthat would be used with the ventilator circuit are generally heavy,especially for pediatric application. Furthermore, the micro pumpnebulizer systems are generally required to be kept upright during use.

Another way in which nebulizing devices have been implemented to avoidconflicting with the sensing mechanisms of a ventilator is to utilizenebulizing systems for delivering target aerosol directly into the lungssuch as a nebulizing catheter synchronized with a patient's breathing toaid in the delivery of expensive or potential toxic drugs, and also toreduce environment contamination with certain drugs. These types ofnebulizing systems are typically driven by a control unit to make surethe pressures of producing the aerosol do not conflict with theventilator circuit activity. Specifically, some nebulizing systems woulduse a separate control unit that synchronizes with the ventilationpressure and only produce aerosol during the initial stages ofinhalation, for example the first 70 percent of inhalation. Thesenebulizing systems are generally designed for higher pressure gas supplyoperation, for example 100 pounds per square inch (p.s.i.) therebyrequiring a separate compressor or gas cylinder in addition to thecontrol unit that manages when the pressurized gas is applied togenerated aerosol.

Accordingly, there is a need for an improved aerosol delivery system foruse with ventilators that makes up for the above-noted issues.

BRIEF SUMMARY

In order to address the concerns of existing nebulizers and nebulizingsystems that can be used with ventilator circuits, a ventilator aerosoldelivery system is disclosed herein which may provide a lightweightportable system that can function without separate control units and usestandard available sources of pressurized gas rather than higherpressure and/or adjustable pressure gas sources often used withnebulizing systems.

According to a first aspect an aerosol delivery system includes a vesselwith a first end comprising a resealable fitting for connecting with agas supply. The vessel also includes a body having a liquid reservoirand a gas passage independent of the liquid reservoir, where the liquidreservoir and the gas passage are in communication with gas supply viathe resealable fitting, and where the body is configured to be adjacentto the resealable fitting when the resealable fitting is attached to thegas supply. A second end of the vessel is connected with a length ofmulti-lumen tubing. The second end defines a liquid path from the liquidreservoir to a liquid lumen in the multi-lumen tubing and a gas pathfrom the gas passage to at least one gas lumen in the multi-lumentubing. The aerosol delivery system also includes a tube adapter, suchas an endotracheal tube adapter, having an inlet port connected to anend of the multi-lumen tubing, and tube opening sized to connect with atube such as an endotracheal tube, where outlets for the gas and liquidlumens at the end of the multi-lumen tubing are arranged such that gasissuing from the at least one gas lumen and liquid issuing from theliquid lumen continuously form an aerosol inside the tube adapter. Gasreceived at the resealable fitting provides gas for both the at leastone gas lumen and provides a pressure to any liquid in the liquidreservoir. In an alternative embodiment, the aerosol delivery system maybe configured for use in endoscopic procedures rather than respiratoryapplications. For example, rather than being connected to anendotracheal tube adapter, the multi-lumen tubing may be connected to atubing, such as a wye-tube, or to a device connected to the tubing, suchas a gas warmer or gas warmer/humidifier device. The tubing carries agas and in one embodiment the gas is CO₂ and it is used in an endoscopicprocedure, such as a laparoscopic procedure, for insufflating a bodycavity and the multi-lumen tubing is used to administer, for example, aliquid such as H₂O in aerosol form, to humidify or to further humidifythe CO₂ gas used to insufflate the body cavity.

The body of the vessel may have a one-way filling port positioned overthe liquid reservoir of the vessel to permit refilling of the reservoir.The one-way filling port may be positioned at an angle from a verticalorientation of the body. The resealable fitting on the vessel may beconfigured to rigidly attach the vessel to an outlet of the gas supply,when the resealable fitting is tightened onto the outlet, so thatorientation of the reservoir is maintained and the reservoir is keptaway from the patient to avoid potential clutter at the location oftreatment. The continuously formed aerosol produced in the endotrachealtube adapter at the end of the multi-lumen tubing may produce particlesizes in a range of 10-14 μm MMAD when gas at a pressure of 50 poundsper square inch (psi) is received at the resealable fitting.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of facilitating an understanding of the subject mattersought to be protected, there is illustrated in the accompanyingdrawings an embodiment thereof, from an inspection of which, whenconsidered in connection with the following description, the subjectmatter sought to be protected, its construction and operation, and manyof its advantages should be readily understood and appreciated.

FIG. 1 illustrates an implementation of a ventilator aerosol deliverysystem connected to a healthcare facility wall-outlet.

FIG. 2 is an enlarged view of the liquid vessel of the ventilatoraerosol delivery system of FIG. 1.

FIG. 3 is a cross-sectional view of the liquid vessel of FIG. 3.

FIG. 4 is a bottom sectional view of the liquid vessel of FIG. 2.

FIG. 5 is an enlarged cross-sectional view of the distal end of theliquid vessel illustrated in FIG. 3.

FIG. 6 is looking proximally at an enlarged partial cross-sectional viewof the distal end of the liquid vessel illustrated in FIG. 3.

FIG. 7 illustrates an endotracheal tube adapter suitable for use in thesystem of FIG. 1.

FIG. 8 is a cross-section of the adapter of FIG. 7 showing a location ofaerosol mist that will be generated by the tip of multi-lumen tubing ofthe system of FIG. 1.

FIG. 9 illustrates an implementation of the ventilator aerosol deliverysystem of FIG. 1 utilizing a gas humidification and warming apparatus.

DETAILED DESCRIPTION

Referring to FIG. 1, an aerosol delivery system 10 is shown connected toa typical wall outlet connection for pressurized gas 12. The typicalwall outlet connection point is a flow meter 13 having a gas flowcontrol knob 11, although the aerosol delivery system 10 may also beconnected directly to the wall outlet. The aerosol delivery system 10includes a liquid vessel 14, multi-lumen tubing 16 carrying the gas anda liquid from the liquid vessel, and a connection such as anendotracheal tube adapter 18 into which an aerosol generated at the endof the multi-lumen tubing 16 is directed. The wall outlet 12 may be atypical healthcare facility wall outlet that provides a supply ofcompressed medical air and is in a fixed position on the wall of thehealthcare facility. The wall outlet 12 may have a suitable DISS(diameter index safety system) fitting connection to the supply ofmedical compressed air at the healthcare facility. A nominal pressure ofmedical air supplied by the wall outlet connection may be 50 p.s.i. Theliquid vessel 14 may directly connect to the wall outlet 12 with athreaded connector 20 that is movably attached to the liquid vessel 14.

As shown in FIGS. 2 and 3, the connector 20 is rotatably attached to anupper portion of the liquid vessel 14 and may be a 9/16-18 UNF femaleconnector with a 10 mm diameter nipple. The connection is designed todirectly interface with the standard 9/16-18 UNF conical male fittingemployed on medical gas flow meters of wall outlets such as wall outlet12. The liquid vessel 14 includes an inlet module 22 and a main body 24.The connector 20 is formed in the inlet module 22. A one-way fillingport 26 on the inlet module 22 provides a port for allowing a liquidmedicament to be added to the liquid vessel 14. The one-way filling port26 may include a Luer fitting to accommodate filling from a standardsyringe in accordance with the ISO 594-1 standard. Also, to allow easieraccess to the filling port and avoid interference from the wall outlet12 or other mounted paraphernalia on a healthcare facility wall, theone-way filling port 26 is formed at an angle from the wall such thatwhen the liquid vessel is attached to the wall outlet, the liquid outletand wall form a non-zero angle, such as a 45 degree angle.

As best shown in FIG. 3, the connector 20 rotatably fits on the end ofan air channel 28 formed in the inlet body 22. The air channel 28 splitsinside the inlet body 22 into a bypass channel 30 and a liquid reservoirchannel 32. The main body 24 of the liquid vessel 14 includes a liquidreservoir region 34 and an air passage 36. The liquid reservoir 34 andair passage 36 are separated by a dividing wall 38 that begins where thebypass channel 30 and liquid reservoir channel 32 separate and continueson until the bottom of the liquid vessel 14 such that two separatechambers are formed. The walls of the main body 24 of the liquid vessel14 surrounding the air passage 36 and liquid reservoir 34 may becompletely transparent, or semi-opaque to permit easy view of any liquidlevels in the liquid reservoir 34 or contaminants in either section. Agroup of liquid vessel graduation marks 40 may be positioned along thevertical length of the main body adjacent the liquid chamber. The liquidvessel graduation marks 40 may be arranged as appropriate for theparticular capacity of the liquid reservoir 34 in the liquid vessel 14.Various capacities of the reservoir for medicament are contemplated, forexample 12 milliliter (mL) or 96 mL versions of the liquid vessel may bedesired. The smaller reservoir may be utilized intended for short termtreatment, analogous to that given by a small volume jet nebulizer,while embodiments with the larger reservoir may be used to delivermedication over extended periods (continuous nebulization), as iscurrently provided by large volume jet nebulizers when used with adrip-bag option. Medication suitable for delivery includes, withoutlimitation, salbutemol, budesonide and ipratropium bromide.

Referring again to FIG. 3, where the air channel 28 splits into a bypasschannel 30 and liquid reservoir air channel 32, the liquid reservoir airchannel 32 provides the top of the reservoir 34 with pressure directlyfrom the wall outlet such that medicament receives enough pressure toforce the liquid through to the bottom of the liquid reservoir 34 to theend of the multi-lumen tubing 16 at the bottom of the liquid reservoir34. The distal end of the liquid reservoir 34 preferably tapers into asmall outlet sized to receive the multi-lumen tubing 16.

At the bottom end of the liquid vessel 14, as noted above, multi-lumentubing 16 is attached at the bottom of the liquid reservoir 34.Additionally, adjacent to the multi-lumen tubing is an opening of theair passage 36. The bottom of the liquid vessel 14, surrounding the airpassage opening 42 and the connection with the multi-lumen tubing 16,defines a connection hub 44. The connection hub 44 may attach to theliquid vessel 14 at a friction fit joint 46 and may additionally oralternatively be bonded or adhered. The multi-lumen tubing 16 may forman adhesive bonded fit, or be joined with the liquid vessel using any ofa number of bonding or welding techniques, with the opening at thebottom of the liquid reservoir 34. The reservoir 34 is sealed to theproximal end of the multi-lumen tube in this manner not only to providean air-tight connection and prevent leakage, but also to preventswitching the liquid vessel 14, or multi-lumen tubing 16 to anothersystem 10, which could lead to contamination or performance issues. Thereservoir 34 is replenished via a syringe connected via the luer-lockfitting of the one-way fill port 26

A liquid filter 48 is positioned at the junction of the reservoir 34 andthe multi-lumen tubing 16 so as to remove any contaminants from liquidprior to entry into the multi-lumen tubing. The liquid filter 48 may bea stainless steel mesh or any of a number of other suitable liquidfilters. In one embodiment, the stainless steel mesh of the liquidfilter may be a steel mesh of approximately 15-25 micrometers (μm) poresize on the stainless steel carrier. The liquid filter 48 may be pressfit into the bottom of the channel in the liquid reservoir.

FIG. 4 illustrates a cross-sectional view of the bottom of the liquidvessel 14 through a portion where the multi-lumen tubing 16 begins. Theparallel air passage outlet 42 and opening in the liquid reservoircontaining the multi-lumen tubing 16 are shown in greater detail. Themulti-lumen tubing 16 includes multiple lumens with a central lumen 50and one or more peripheral lumens 52. The multi-lumen tubing terminatesin the endotracheal tube adapter 18 in a tapered portion with the lumensaligned to generate an aerosol as the air and liquid are ejected underpressure supplied by the wall-outlet 12. Various arrangements andpositioning of tubing with multiple lumens are contemplated. Examples ofvarious suitable multi-lumen tubing 16 may be found in U.S. Pat. No.5,964,223, entitled Nebulizing Catheter System and Methods of Use andManufacture, the entirety of which is incorporated herein by reference.

At the initial portion of the multi-lumen tubing 16 where liquid fromthe liquid reservoir 34 enters the multi-lumen tubing 16, all of thelumens 50-52 receive liquid. Referring to FIGS. 5-6, a break 54 in someof the lumens allows selective blocking of those lumens in themulti-lumen tubing 16 just below the connection of the multi-lumentubing 16 to the liquid reservoir 34. This break 54 is used topreferably block one or more of the peripheral lumens 52 so that noliquid from the liquid reservoir 34 may pass further down themulti-lumen tubing 16 through the blocked lumens. The blockage of thelumens may be performed by a heat melting of the extruded multi-lumentubing or applying a glue that blocks specific lumens in the multi-lumentubing. In the five peripheral lumen 52 embodiment illustrated, allperipheral lumens may be blocked at the break 54 in one implementation.

Further down the multi-lumen tubing 16, away from the liquid vessel withrespect to the break 54, are lumen openings 56 that provide an avenue tocommunicate air coming from the air outlet 42 of the air passage 36 tothe lumens 52 that were blocked at the break 54. Air traveling throughthe connection hub 44 is directed into the openings 56 and thus to thedistal end of the multi-lumen tubing 16. In other words, pressurized airfrom the wall outlet 12 which passes through the air passage 36 in airoutlet 42 into the connection hub 44 is then projected into the openlumens at the opening 56. Medicament from the liquid reservoir 34 in theliquid vessel 14 continues in the multi-lumen tubing 16 in a centrallumen 50 and/or any other lumens not blocked at the blocking portion 54.

The distal end of the connection hub 44 is sealed around the multi-lumentubing 16, for example with an adhesive or glue, to prevent gas leakage.A strain relief member 58 is attached to the end of the connection hub44. The strain relief member 58 may be a bendable tip having a lengthsufficient to provide a transition between the rigid connection hub 44and the more flexible multi-lumen tubing 16. Also, as best shown inFIGS. 2 and 3, the connection hub 44 tapers and curves away from theside of the liquid vessel 14 intended to be oriented nearest a wall whenthe connector 20 is attached to the healthcare facility gas supplyoutlet 12. In this manner, the multi-lumen tubing 16 and strain relieftip 58 are spaced away from the wall, when the connector 20 is attachedto the wall-mounted gas supply, and are less likely to interfere withother equipment, tubing or outlets that may be mounted on or near thesame wall.

In operation, the multi-lumen tubing 16 leaving the strain relief region58 contains the flow of air from the wall-mounted outlet 12 in theperipheral lumens 52 and liquid in the central lumen 50. The multi-lumentubing 16 preferably extends from the liquid vessel 14 to an adaptersuch as the endotracheal tube adapter 18 over a distance ofapproximately 2 to 3 meters. The multi-lumen tubing 16 connects with theendotracheal tube (ETT) adapter 18 over a short strain relief sleeve 60to provide strain relief at the point where the multi-lumen tubing andthe endotracheal tube adapter meet. As shown in FIGS. 7-8, the ETTadapter 18 has an ET Tube connection end 62 for connecting toendotracheal tube, an insertion port 64 sized to receive the multi-lumentubing 16 and strain relief sleeve 60, and a suction catheter connectionport 66 for receiving a suction catheter. The ET Tube connection end maybe a standard 15 mm diameter tapered connection in compliance with ISOstandard 5356-1.

The tip of the multi-lumen tubing 16 is preferably tapered such that thetubing 16 extends into the insertion port 64 slightly more than thesleeve 60 and the air and liquid lumens 52, 50 are oriented to mix theair and liquid into a nebulized mist 68 into the ETT adapter 18 as shownin FIG. 8. In one implementation, the multi-lumen tubing 16 may betubing having a nominal 2 mm outside diameter at its proximal end (i.e.adjacent the liquid vessel 14) and tapering to about 0.4 to 0.6 mm, butpreferably about 0.5 mm, outside diameter over the portion that extendsinto the insertion port 64 of the ETT adapter 18. A desired range ofparticle sizes is 10-14 μm mass median aerodynamic diameter (MMAD) whenair at a pressure of 50 pounds per square inch (psi) (345 kiloPascals(kPa)) is applied to the gas lumens 52 and to liquid in the reservoir 34of the liquid vessel 14. The resultant air flow-rate may be on the orderof 0.6 L/minute (600 mL/min) and the liquid flow-rate may be about 0.4mL/minute.

The size of the multi-lumen tubing 16 and lumens 50, 52 may be selectedto achieve desired particle size and flow rates for a given gaspressure. In one embodiment the multi-lumen tubing 16 may have onecentral lumen and several outside lumens, typically 4 to 6, with nominaldiameters of 0.012 inches and 0.02 inches respectively at the proximalend. The multi-lumen tubing can be provided in various lengths, with onesuitable length being about 3 meters as mentioned above. At the tip ofthe multi-lumen tubing inside the insertion port 64, the outer lumens 52may be sized with a diameter 0.0032±0.00015″ and the inner lumen(carrying the liquid under pressure provided from a portion of the gassupply of the wall outlet 12) may be size at a diameter of0.0024±0.00005″. The outer lumens may be arranged on a 0.0074±0.00006″pitch circle diameter. One can produce a different particle sizedistribution with the system by adjusting the lumen 50, 52 diameterswhile maintaining the same wall thickness between the lumens.

Preferably the multi-lumen tubing 16, liquid vessel 14, and filterelement 48 will all be made of chemically-resistant materials suitablefor working with the medications intended, including, withoutlimitation, salbutemol, budesonide and ipratropium bromide. Generallythese materials should satisfy USP class VI (ISO 10993-1). One generallygood material for the multi-lumen tubing is a polyamide, such asNylon-12. As noted above, the filter element 48 may be a stainless steelmesh of a stainless steel carrier. I an alternative embodiment, thefilter may be a monofilament polyamide, such as Nylon 6-6 (SefarMedifab). Other materials are contemplated. The endotracheal tubeadapter 18 and the components of the liquid vessel 14 generally shouldbe made of a durable, biocompatible material with a reasonable degree ofimpact resistance. As noted above, the main body 24 of the liquid vessel14 may be clear or have a clear section to provide a room for visualassessment of the amount of liquid within reservoir 34. One suitablematerial for these components is Zylar (a styrene methyl methacrylateacrylic copolymer).

The connector 20 at the side of the of the inlet module 22 of the liquidvessel 14 may be made from ABS or other material with a suitablestrength. The one-way fill port 26 may be made from a combination ofmaterials, such as ABS and silicone rubber. The strain reliefs tip 58and sleeve 60 may be made from a flexible material that can be readilybonded to the associated parts. The strain relief tip and sleeve 58, 60are preferably not in contact with the medical gas or liquid medicationand a suitable material for these elements is PVC or polyurethane. Also,the bonding of adjacent parts in the system 10 should satisfybiocompatibility requirements for any of the airways or liquid pathways.Examples of suitable bonding techniques include ultrasonic welding orUV-curing adhesives. Although reusable versions are contemplated, theaerosol delivery system 10 is preferably a single-use, disposable item.

Although numerous configurations are contemplated, in oneimplementation, the following dimensions may be used. The liquid vessel14 may have an inlet module 22 that fits within a 24×13 mm cross-sectionand is approximately 34 mm high for a 10 mL reservoir 34, or can fit ina 48×42 mm cross-section and is approximately 42 mm high for a 100 mLreservoir 34. The main body of a 10 mL version and a 100 ml version maybe 83 mm high and 126 mm high, respectively, and fit within the samerespective cross-sections identified above. The one-way filling port 26may be 1.75″ long with a 0.25″ outside diameter and a 0.375″ diameterouter flange. The connection hub 44 may fit within a 0.3″×0.5″cross-sectional area and is nominally 1.4″ to 1.8″ in length. The strainrelief tip 58 is nominally 25 mm in length with inside dimensions to fitthe tip of the Connection Hub 44 and the nominal 2-mm-diameter proximalend of the multi-lumen tubing 16. In the liquid vessel 14, the airpassage 36 within the main body 24 is nominally 4×8 mm in cross-section.For the portion of the air inlet 28 that branches into the liquidreservoir air channel 32, the nominal ⅛″ diameter inlet 28 is dividedinto two channels that provide inlets to the air passage 36 and theinlet to the liquid reservoir 34. The inlet of the liquid reservoir airchannel 32 to the liquid reservoir 34 is on the order of 1.5 mm². Also,the inside and outside diameters of the strain relief sleeve 60 arenominally 1/16″ and ⅛″ respectively, with a length sufficient to providea snug fit at its proximal contact with the multi-lumen tubing 16. Thislength may be typically 30 cm.

In operation, the system 10 provides for continuous aerosolization of amedication that has been provided in a suitable concentration to permitcontinuous delivery until the reservoir 34 of the liquid vessel 14 isempty. A brief description of system set-up and operation is describedbelow. A packaged system 10 may be opened by a healthcare provider andinspected for any signs of damage or broken seals on the package. Afterremoval from the packaging, the healthcare provider connects theconnector 20, such as a 9/16-18 UNF female connector, to the supply ofmedical gas from a wall-mounted flow-meter 12. The multi-lumen tubing 16is then uncoiled and the endotracheal tube adapter 18 may be connectedthe endotracheal tube, a suction catheter (if required) and ventilatorcircuit. Clips or other suitable restraints may be applied along thelength of the multi-lumen tubing 16, as necessary, to ensure that thetubing 16 does not accidentally experience excessive forces while inuse.

Once the system 10 is secured and assembled, the healthcare provider mayprovide medicament to the reservoir 34 or the system 10 may be prefilledand packaged with the desired medication. In one implementation, it iscontemplated that the healthcare provider could insert a pre-filledsyringe into the one-way filling port 26 and twist the tapered Luerconnection of the port to ensure a firm contact. If necessary, thehealthcare provider may repeat this filling process until the desiredvolume of liquid medication is in the reservoir 34. The graduations 40on the main body 24 of the liquid vessel 14 may be used to confirm thatthe desired amount of medication has been introduced into the liquidvessel 14. The flow through the flow regulator of the healthcarefacility wall outlet 12 may now be adjusted to maximum, since thedimensions of the outer lumens of the multi-lumen tubing will govern theflow-rate of air exiting the tip of the multi-lumen tubing 16 in the ETTadapter 18. At this stage, the aerosol 66 generated at the tip of themulti-lumen tubing 16 will begin to be delivered into an ET Tube (notshown) connected to the ETT adapter 18. If the liquid vessel 14 requiresre-filling during the treatment of the patient, the fresh liquidmedication can be introduced using a syringe while the circuit is stillpressurized at 50 psi. The pressure required on the plunger of thesyringe when filling a pressurized circuit will be greater than when thecircuit was not pressurized, but should still be achievable with a forceapplied by the thumb and fingers of one hand. When the treatment iscomplete, the flow meter to may be adjusted to zero flow, the 9/16-18UNF female connector removed from the flow meter, and the system 10disconnected from the ET Tube, suction catheter (if present), and theventilator circuit. The system 10 should then be completely disposed ofas required by the procedures of the healthcare facility.

An additional embodiment directed to an apparatus for use in anendoscopic procedure is illustrated in FIG. 9. Rather than using thesystem 10 for a respiratory application, the system may be modified forendoscopic applications by removing the ventilator adaptor 18 of FIGS.7-8 (see also FIG. 1) and instead inserting the multi-lumen tubing 16into a port of a gas warmer and/or humidifier 100 such as shown. Themulti-lumen tubing may be a nebulizing catheter that is designed topierce a membrane on the port of the gas warmer and/or humidifier andintroduce a nebulized substance into the gas warmer, or it may terminatein any of a number of known connectors designed to cooperate with theport on the gas warmer and/or humidifier. The multi-lumen tubing 16 canbe inserted in the port to humidify a gas exiting the gas warmer, suchas the carbon dioxide (CO₂) gas, or to add a medicament to the CO₂ gasexiting the gas warmer. In alternative embodiments, the multi-lumentubing may be connected to a gas warmer only or directly to the tubing,such as a wye-tube, via a suitable air tight connector.

As shown in FIG. 9 a gas inlet port 112 is attached through a sideportion of a front cap 113 of the gas humidification apparatus 100. Inaddition, an inlet port 115 is attached through a central portion of thefront cap 113. The inlet port 115 allows for electrical components andwiring to be inserted into the gas humidification apparatus 100. The gashumidification apparatus 100 can be modified so that the ports 112 and115 are interchanged with one another. The cap 113 may include anannular metallic heater housing (not shown) within the device housing126 in fluid communication with the gas inlet port 112. The heaterhousing contains a heater cartridge that is well known in the art. Whenactivated, the heater cartridge heats up the interior and body of theheater housing so that gases within and outside the heater housing areheated. The heater housing may include a plurality of circular holeshaving a diameter of approximately 0.1″ (0.254 cm). Other shapes andsizes for the holes are possible, such as triangular and square shapedopenings. When gas flows into the gas humidification apparatus 100 viathe gas inlet port 112, the gas flows into the heater housing, where itis heated if necessary, and then flows out of the holes. The holes ofthe heater housing may improve the rate of heating of the gas within thegas humidification apparatus 100 and create turbulence for the gasflowing within the gas humidification apparatus 100.

The housing 126 of the gas humidifier includes a first port 116 thatallows fluid to be infused by syringe, gravity feed through tubing, orby any number of pumps, to the humidification material 124. The fluidsinfused may include sterile water, medication, or a mixture of fluidsrequired for merely humidification or dispensing of medication. Theinterior end of the port 116 is positioned so that infused fluids dripinto the housing 116 and are soaked up by the entire humidificationmaterial 124 by capillary action. The housing 126 may also include asecond port 118. The second port 118 is positioned between thehumidification material 124 and the outlet 128 so as to allow a distalend of a catheter, such as the multi-lumen tubing 16, to be insertedinto the port 118. Depending on the intended material to be delivered tothe patient, the distal end of the catheter may be positioned within theport 118, within the interior of the gas humidification apparatus 100 orwithin a tube attached to the outlet 128 and in fluid communication witha section of a patient, or within the section of the patient. An exampleof a catheter that can be inserted into the gas humidification apparatus100 is the catheter described in U.S. Pat. No. 5,964,223, previouslyincorporated by reference. Other devices can be inserted into the port118 in a similar manner, such as a lumen and an endoscope. Furthermore,gases, liquids, aerosols and medicines may be conveyed to a patient by atube or other know dispensing devices inserted through the port 118 andexiting out of the outlet 128 into the patient. Note that the materialsdispensed into the port 118 by the above-mentioned dispensing devicesmay have properties that raise the humidity of the gas within theinterior of the gas humidification apparatus 100.

The gas humidification apparatus 100 may include control circuitry 120that is in communication with the housing via inlet port 115. Thecontrol circuitry may include temperature sensors, humidity sensors andcontrol circuitry so that the temperature and humidity of the gasflowing within the apparatus and delivered to a patient is controlled.In the implementation of FIG. 9, an aerosol delivery system includingthe liquid vessel 14, multi-lumen tubing 16 and gas humidifier 100 maybe used for endoscopic procedures, such as a laparoscopic procedure.Other configurations are also contemplated.

An aerosol delivery system 10 has been described that, in oneimplementation, may be a single-use (disposable) continuous nebulizersystem designed for use with mechanically ventilated patients toaerosolize physician-prescribed medications for inhalation which areapproved for use with a general purpose nebulizer. The system 10separates the liquid reservoir from the nebulization process takingplace at the adapter hub where it fits into an endotracheal tube (ETT)by a long (for example 3 meter) multi-lumen tube 16 comprising multipleouter lumens 52 supplying air with the central lumen 50 containing theliquid to be nebulized as the result of the Venturi effect at its distalend where it comes into contact with the air supply. The liquidreservoir 34 can therefore be mounted away from the immediate treatmentzone, avoiding concerns about the effect of orientation that areassociated with other types of nebulizers having a self-containedreservoir. The system can produce aerosols having a wide range ofdroplet sizes, depending upon central lumen diameter, with values ofMMAD that range from 4 to 30 μm. In another implementation, the aerosoldelivery device may be configured for non-respiratory applications, suchas endoscopic procedures including laparoscopy, for example by insertingthe distal end of the multi-lumen tubing into an inlet port of a tubing,a gas warmer, a gas warmer/humidifier or other device suitable for usein an endoscopic procedure, rather than into an endotracheal tubeadapter.

It is therefore intended that the foregoing detailed description beregarded as illustrative rather than limiting, and that it be understoodthat it is the following claims, including all equivalents, that areintended to define the scope of this invention.

We claim:
 1. An aerosol delivery system comprising: a vessel comprising:a first end comprising a resealable fitting for connecting with a gassupply; a body having a liquid reservoir and a gas passage independentof the liquid reservoir, wherein the liquid reservoir and the gaspassage are in communication with gas supply via the resealable fitting,and wherein the body is configured to be adjacent to the resealablefitting when the resealable fitting is attached to the gas supply; and asecond end connected with a length of multi-lumen tubing, the second enddefining a liquid path from the liquid reservoir and to a liquid lumenin the multi-lumen tubing and a gas path from the gas passage to atleast one gas lumen in the multi-lumen tubing; a tube adapter having aninlet port connected to an end of the multi-lumen tubing, a tube openingsized to connect with a tube, wherein outlets for the gas and liquidlumens at the end of the multi-lumen tubing are arranged such that a gasissuing from the at least one gas lumen and liquid issuing from theliquid lumen continuously form an aerosol inside the tube adapter; andwherein the gas is received at the resealable fitting and provides gasfor the at least one gas lumen and provides a pressure to a liquid inthe liquid reservoir.
 2. The aerosol delivery system of claim 1, whereinthe body further comprises a one-way filling port positioned over theliquid reservoir of the vessel, the one-way filling port positioned topermit refilling of the reservoir.
 3. The aerosol delivery system ofclaim 2, wherein the one-way filling port is positioned at an angle froma vertical orientation of the body.
 4. The aerosol delivery system ofclaim 3, wherein the vessel and the tube adapter are separated by atleast 3 feet by the multi-lumen tubing.
 5. The aerosol delivery systemof claim 4, wherein the resealable fitting on the vessel is configuredto rigidly attach the vessel to an outlet of the gas supply, when theresealable fitting is tightened onto the outlet.
 6. The aerosol deliverysystem of claim 4, wherein the multi-lumen tubing is at least 8 feetlong.
 7. The aerosol delivery system of claim 5, wherein thecontinuously formed aerosol produced in the endotracheal tube adaptercomprises particle sizes in a range of 10-14 μm MMAD when gas at apressure of 50 pounds per square inch (psi) is received at theresealable fitting.
 8. The aerosol delivery system of claim 1, whereinthe liquid comprises one or more of salbutemol, budesonide andipratropium.
 9. The aerosol delivery system of claim 1, wherein the bodyis configured to be vertically aligned by the resealable fitting whenthe resealable fitting is attached to the gas supply.
 10. The aerosoldelivery system of claim 1, wherein the tube opening of the tube adapteris sized to connect with an endotracheal tube.
 11. The aerosol deliverysystem of claim 10, wherein the tube adapter further comprises a suctioncatheter opening sized to connect with a suction catheter.
 12. Theaerosol delivery system of claim 1, wherein the tube adapter comprisesan endotracheal tube adapter.
 13. The aerosol delivery system of claim1, wherein the tube adapter comprises a wye-tube.
 14. An aerosoldelivery system comprising: a vessel comprising: a first end comprisinga resealable fitting for connecting with a gas supply; a body having aliquid reservoir and a gas passage independent of the liquid reservoir,wherein the liquid reservoir and the gas passage are in communicationwith gas supply via the resealable fitting, and wherein the body isconfigured to be adjacent to the resealable fitting when the resealablefitting is attached to the gas supply; and a second end connected with alength of multi-lumen tubing, the second end defining a liquid path fromthe liquid reservoir and to a liquid lumen in the multi-lumen tubing anda gas path from the gas passage to at least one gas lumen in themulti-lumen tubing; an inlet port resealably connected to an end of themulti-lumen tubing, wherein outlets for the gas and liquid lumens at theend of the multi-lumen tubing are arranged such that a gas issuing fromthe at least one gas lumen and liquid issuing from the liquid lumencontinuously form an aerosol at the inlet port; and wherein the gas isreceived at the resealable fitting and provides gas for the at least onegas lumen and provides a pressure to a liquid in the liquid reservoir.15. The aerosol delivery system of claim 14, wherein the gas isconfigured for use in an endoscopic procedure.